Able Laboratories, Inc. (Able) develops, makes and sells generic drugs, which are the chemical and therapeutic equivalents of brand-name drugs. The Company manufactures and sells a range of prescription pharmaceutical products in solid oral dosage and suppository forms. Able markets its generic drug products under its Able Laboratories label, as well as under private label arrangements. The Company's products are sold primarily through direct sales efforts to drug wholesalers, distributors and retail drug chains. Able's products that have been approved by the United States Food and Drug Administration (FDA) include Acetaminophen and Codeine Phosphate tablets, Atenolol tablets, Bethanechol Chloride tablets, Butalbital, Acetaminophen, Caffeine tablets and Butalbital, Acetaminophen, Caffeine and Codeine Phosphate capsules. Other products that have been approved by the FDA are Carisoprodol tablets, Clorazepate Dipotassium tablets, Dextroamphetamine Sulfate Extended-Release capsules, Diphenoxylate Hydrochloride and Atropine Sulfate tablets and Hydrocodone Bitartrate and Acetaminophen tablets. Antipsychotic products include Lithium Carbonate capsules and Lithium Carbonate Extended-Release tablets, while antibiotic products include Metronidazole tablets, Metronidazole Extended-Release tablets and Metronidazole capsules and vasodilators include Nitrotab Nitroglycerin Sublingual tablets. Able received its first FDA approval to manufacture and sell Diphenoxylate Hydrochloride and Atropine Sulfate tablets in November 2000. As of February 15, 2005, Able has six Abbreviated New Drug Applications (ANDAs) pending approval at the FDA. Prior to FDA approval of an ANDA, the Company may undergo an on-site inspection, known as a pre-approval inspection (PAI) by the district office of the FDA. Between January 2001 and February 15, 2005, Able has had several Current Good Manufacturing Practice (cGMP) and pre-approval inspections, covering several products. The Company's product development program includes several active projects in various stages of completion. Able manufactures its generic products at its facilities in South Plainfield, New Jersey. The principal components used in the manufacture of generic products are active and inactive pharmaceutical ingredients and certain packaging materials. The FDA must approve its sources for almost all of the materials. In many instances, only one source may have been approved. The Company purchases active raw material ingredients primarily from United States distributors of bulk pharmaceutical materials manufactured by United States or foreign companies. If active raw materials from an approved supplier were to become unavailable, Able would have to file and obtain FDA approval of a supplement to the applicable ANDA. In 2004, the Company manufactured over 1.3 billion tablets, capsules and suppositories.

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